# K172413: MT ONE

- Pathway: 510(k) (Traditional)
- Applicant: M&T S.R.L.
- Decided: Oct 6, 2017 after 57 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 531 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 537 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152714: Quanta Forte, Quanta System Spa (2015) Summary page 5.
- K111303: Dermatological Treatment Device Family, Sharplight Technologies, Ltd. (2011) Summary page 5.

## Most influential descendants
- K192856: MT One (2020), 2 descendants of its own
- K203395: Platform treatment system (2022), 1 descendant of its own
- K191942: MT One Diamond (2019), 1 descendant of its own
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own
- K200736: Stardust Med (2020), 0 descendants of its own

## Indications for use
MT ONE and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery. MT ONE with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*. MT ONE with AC415-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick Scale. MT ONE with VLPL535-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale. MMT ONE with HR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick Scale. MMT ONE with SR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick Scale. MMT ONE with HR635-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick Scale. MT ONE with Er-Yag2940USnm Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). MT ONE with Nd:YAG1064(LP)USnm Laser Handpiece is indicated for: - Removal of unwanted hair, for stable long term, or permanent, hair reduction* through selective targeting of melanin in hair follicles; - Removal or lightening of unwanted hair (with or without adjuvant preparation); - Treatment of pseudofolliculitis barbae (PEB). *Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K172413
Methodology: https://510kreport.com/methodology